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CTRI Number  CTRI/2024/08/073154 [Registered on: 30/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to compare the effect USG guided single injection Erector Spinae Plane Block and Serratus Anterior Plane Block for postoperative analgesia in thoracic surgery  
Scientific Title of Study   Comparison of USG guided single injection Erector Spinae Plane Block versus Serratus Anterior Plane Block for postoperative analgesia in thoracic surgery A Randomised Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preetha V R 
Designation  Post Graduate Student 
Affiliation  DR SN Medical College 
Address  Cardiothoracic OT MDM Hospital, DR.SN Medical college Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342003
India 
Phone  9791920399  
Fax    
Email  preegingee@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Karnawat 
Designation  Senior Professor 
Affiliation  DR SN Medical College 
Address  Cardiothoracic OT, MDM Hospital DR SN Medical College Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Karnawat 
Designation  Senior Professor 
Affiliation  DR SN Medical College 
Address  Cardiothoracic OT, MDM Hospital DR SN Medical College Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Source of Monetary or Material Support  
MDM Hospital DR SN Medical College Jodhpur Rajasthan India Pincode:342003 
 
Primary Sponsor  
Name  DR SN Medical College 
Address  DR SN Medical College, Residency Road, Sector D, Shastri Nagar, Jodhpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preetha V R  Mathura Das Mathur Hospital  OT NO:1 Cardiothoracic department Cardiothoracic OT, MDM Hospital Shastri Nagar, Jodhpur
Jodhpur
RAJASTHAN 		 9791920399

preegingee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, DR SN Medical College, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A:Serratus Anterior Plane Block  US-guided SAPB will be administered with 20 mL of 0.25% bupivacaine at the fifth rib, in the midaxillary line in transverse plane for Group A patients 
Comparator Agent  Group:B Erector Spinae Plane Block  US-guided ESPB will be administered with 20 mL of 0.25% bupivacaine at the T5 vertebral level for Group B patients 
Intervention  USG Guided ESP Block and SAP Block in Thoracic Surgeries  Comparison Between USG Guided ESP Block and SAP Block for postoperative analgesia in Thoracic Surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details   Adult patients, aged between 18 to 45 years and undergoing elective Thoracic surgeries under general anesthesia who belongs to ASA PSI, II  
 
ExclusionCriteria 
Details  1.Patients with BMI more than 30 kg/m2 or BMI less than 18 kg/m2
2.Patient refusal
3.Age less than 18 years old
4.Pregnant woman
5.History of any allergy to related perioperative medications
6.Previous lumbar spine surgery
7.Existing contraindications to nerve block such as coagulopathy, local and systemic infections
8.Those patients who are intubated for more than 4 hours postoperatively and shifted to postoperative ward will be excluded from the study
9. Patients who experience block failure
10.Those patients complaining of pain within 2 hours of postoperative period will be considered as block failure and are excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary objective to compare SAPB or ESPB for postoperative analgesia following thoracic surgery, as determined by the time until the first analgesic requirement in the postoperative period  The primary objective to compare SAPB or ESPB for postoperative analgesia following thoracic surgery, as determined by the time until the first analgesic requirement in the first 24 hours postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
1.VAS score at rest and while coughing at 2, 4, 8, 24, 48 hours postoperatively
2.Consumption of injection tramadol in first 24 hours of postoperative period
3.Hemodynamic parameters
4.Block related complications hematoma, pneumothorax, nerve injury till a period of 2 weeks
5.Length of Hospital stay 		 1.VAS will be recorded after the extubation, and at interval of 10 min thereafter till 60 mins to confirm the time of onset analgesia, then interval of hourly upto 4 hours followed by every 4 hours up to 24 hours post-operative
2.Hemodynamic parameters will be monitored after extubation and at the interval of 10min thereafter till 60 mins, then hourly upto 4 hours followed by 4 hourly upto 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preegingee@gmail.com].

  6. For how long will this data be available start date provided 05-11-2025 and end date provided 05-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Comparison of  USG guided single injection erector spinae plane block versus serratus anterior plane block for postoperative analgesia in thoracic surgery.  Ultrasound-guided ESPB and SAPB are two most common analgesic methods that are simple, associated with high safety and good analgesic effect. The main objective of this study is to compare the efficiency of ultrasound-guided ESPB and SAPB for postoperative analgesia and inflammation control in patients.

 
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